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Acute decompensated heart failure (ADHF) is a clinical syndrome associated with high morbidity and mortality rates. Current guidelines emphasize the importance of oxygenation and diuresis in the management of ADHF. However, there is no clear recommendation regarding whether diuretic therapy should be administered as intermittent bolus dosing or continuous infusion. The aim of this study was to compare the early efficacy of bolus versus continuous infusion diuretic therapy in the emergency department management of ADHF. In this single-center, prospective, randomized, double-blind, parallel-group clinical trial, patients aged ≥18 years presenting with ADHF and without known chronic kidney disease were randomized in a 1:1 ratio to receive either intermittent bolus therapy or continuous infusion therapy. Allocation concealment was ensured using opaque sealed envelopes. To maintain blinding, simultaneous placebo-like administrations were performed in both groups. The primary endpoint was total urine output at 2 and 4 hours. Secondary endpoints included changes in the internal jugular vein collapsibility index (JVCI) at 2 and 4 hours. Tertiary end point was spot urinary sodium at 2 and 4 hours.
Acute decompensated heart failure (ADHF) is a common cause of emergency department admission and is associated with significant morbidity and mortality. Intravenous loop diuretics remain the cornerstone of treatment for patients presenting with volume overload. However, the optimal method of administration-intermittent bolus versus continuous infusion-remains controversial.
Most randomized studies comparing these strategies have been conducted in hospitalized patients and have focused on outcomes measured over longer observation periods. Data evaluating the early response to diuretic therapy in the emergency department setting are limited.
This prospective, randomized, double-blind clinical study aimed to compare the early effects of intravenous bolus versus continuous infusion furosemide therapy in patients presenting to the emergency department with acute decompensated heart failure.
Eligible patients were randomly assigned to receive either intermittent intravenous bolus furosemide or continuous infusion furosemide. Blinding was achieved by administering placebo infusion or placebo bolus according to treatment allocation. The primary outcome of the study was cumulative urine output during the first four hours after treatment initiation. Secondary outcomes included changes in the internal jugular vein collapsibility index measured by bedside ultrasound. The tertiary outcome was the spot urinary sodium at 2nd and 4th hours of study The study also evaluated the potential role of internal jugular vein collapsibility index as a dynamic and non-invasive parameter for monitoring systemic congestion during early diuretic therapy in the emergency department.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bolus Group | Experimental | Patients in this group received an intravenous bolus equivalent to 2.5 times their total daily oral diuretic dose in 10mL syringe. Blinding was ensured by administering 100 mL of intravenous continuous infusion normal saline as a placebo. |
|
| İnfusion Group | Experimental | Patients in this group received an intravenous continious infusion equivalent to 2.5 times their total daily oral diuretic dose in 100mL saline bag. Blinding was ensured by administering 10 mL syringe of intravenous bolus normal saline as a placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide Bolus | Drug | atients in this group received 2.5 times their usual daily diuretic dose administered as an intravenous bolus infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diuresis | Total cumulative urine output | 2nd and 4th hours after administration of Furosemide |
| Measure | Description | Time Frame |
|---|---|---|
| Juguler Venous Collapsibility Index Change | Change from baseline in internal jugular vein collapsibility index (JVCI) at 2 and 4 hours, measured by bedside ultrasonography. | after administration of furosemide, 2nd and 4th hour |
| Measure | Description | Time Frame |
|---|---|---|
| Spot Urinary Sodium | Spot urine sodium concentration measured after initiation of diuretic therapy to evaluate early natriuretic response. | 2 hours and 4 hours after Furosemide administration |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sultan 2. Abdulhamid Han Research and Training Hospital | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33620424 | Background | Tersalvi G, Dauw J, Gasperetti A, Winterton D, Cioffi GM, Scopigni F, Pedrazzini G, Mullens W. The value of urinary sodium assessment in acute heart failure. Eur Heart J Acute Cardiovasc Care. 2021 Apr 8;10(2):216-223. doi: 10.1093/ehjacc/zuaa006. | |
| 33689236 | Background | Zheng Z, Jiang X, Chen J, He D, Xie X, Lu Y. Continuous versus intermittent use of furosemide in patients with heart failure and moderate chronic renal dysfunction. ESC Heart Fail. 2021 Jun;8(3):2070-2078. doi: 10.1002/ehf2.13286. Epub 2021 Mar 10. |
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Study protocol will be shared but Our clinical datas' are not available for sharig considering ethical problems.
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Double Blind (Participant, Care Provider, Outcomes Assessor)
| Furosemide Continuous İnfusion | Drug | Patients in this group received 2.5 times their usual daily diuretic dose administered as an intravenous continious infusion |
|
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| 33850914 | Background | Suri SS, Pamboukian SV. Optimal diuretic strategies in heart failure. Ann Transl Med. 2021 Mar;9(6):517. doi: 10.21037/atm-20-4600. |
| 35676916 | Background | Fatima S, Lambert W, Nouraie M, Pacella J. Bedside ultrasound to assess acute central venous pressure change during treatment of decompensated heart failure. Int J Cardiol Heart Vasc. 2022 Jun 2;41:101067. doi: 10.1016/j.ijcha.2022.101067. eCollection 2022 Aug. |
| 29761678 | Background | Tzadok B, Shapira S, Tal-Or E. Ultrasound of Jugular Veins for Assessment of Acute Dyspnea in Emergency Departments and for the Assessment of Acute Heart Failure. Isr Med Assoc J. 2018 May;20(5):308-310. |
| 31040727 | Background | Jassim HM, Naushad VA, Khatib MY, Chandra P, Abuhmaira MM, Koya SH, Ellitthy MSA. IJV collapsibility index vs IVC collapsibility index by point of care ultrasound for estimation of CVP: a comparative study with direct estimation of CVP. Open Access Emerg Med. 2019 Apr 3;11:65-75. doi: 10.2147/OAEM.S176175. eCollection 2019. |
| 21366472 | Background | Felker GM, Lee KL, Bull DA, Redfield MM, Stevenson LW, Goldsmith SR, LeWinter MM, Deswal A, Rouleau JL, Ofili EO, Anstrom KJ, Hernandez AF, McNulty SE, Velazquez EJ, Kfoury AG, Chen HH, Givertz MM, Semigran MJ, Bart BA, Mascette AM, Braunwald E, O'Connor CM; NHLBI Heart Failure Clinical Research Network. Diuretic strategies in patients with acute decompensated heart failure. N Engl J Med. 2011 Mar 3;364(9):797-805. doi: 10.1056/NEJMoa1005419. |
| 28940440 | Background | Ng KT, Yap JLL. Continuous infusion vs. intermittent bolus injection of furosemide in acute decompensated heart failure: systematic review and meta-analysis of randomised controlled trials. Anaesthesia. 2018 Feb;73(2):238-247. doi: 10.1111/anae.14038. Epub 2017 Sep 22. |
| 36909062 | Background | Karedath J, Asif A, Tentu N, Zahra T, Batool S, Sathish M, Sandhu QI, Khan A. Continuous Infusion Versus Bolus Injection of Loop Diuretics for Patients With Congestive Heart Failure: A Meta-Analysis. Cureus. 2023 Feb 8;15(2):e34758. doi: 10.7759/cureus.34758. eCollection 2023 Feb. |
| 23683555 | Background | Alqahtani F, Koulouridis I, Susantitaphong P, Dahal K, Jaber BL. A meta-analysis of continuous vs intermittent infusion of loop diuretics in hospitalized patients. J Crit Care. 2014 Feb;29(1):10-7. doi: 10.1016/j.jcrc.2013.03.015. Epub 2013 May 14. |
| 36035285 | Background | Huang Y, Guo F, Chen D, Lin H, Huang J. Comparison of Different Furosemide Regimens in the Treatment of Acute Heart Failure: A Meta-Analysis. Comput Math Methods Med. 2022 Aug 18;2022:4627826. doi: 10.1155/2022/4627826. eCollection 2022. |
| 34447992 | Background | McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available. |
| 35379503 | Background | Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 May 3;79(17):e263-e421. doi: 10.1016/j.jacc.2021.12.012. Epub 2022 Apr 1. |